Fexofenadine Hydrochloride Tablet, Film Coated
NDC Package 45802-847-78

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fexofenadine Hydrochloride tablets is adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-847 and is authorized under FDA application ANDA212971.

Identification & Billing

NDC Package Code
45802-847-78
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
Product Code
45802-847
11-Digit Billing Format
45802084778
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fexofenadine Hydrochloride
Non-Proprietary Name
Fexofenadine Hydrochloride
Substance Name
Fexofenadine Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FEXOFENADINE HYDROCHLORIDE 180 mg/1
Pharmacologic Class
Usage Information
Adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Otc Drug
FDA Application #
ANDA212971
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-07-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45802-847-78 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet, film coated in 1 bottle of Fexofenadine Hydrochloride, a human over the counter drug labeled by Padagis Israel Pharmaceuticals Ltd. This tablet, film coated is formulated for oral use and contains fexofenadine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Padagis Israel Pharmaceuticals Ltd on January 07, 2022. The current certification is valid through December 31, 2026.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802084778. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
45802-847-78
11-Digit CMS (5-4-2)
45802-0847-78

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.